During standard surgical procedures, the surgeon requires access to and use of a large number and variety of instruments, such as scalpels, scissors, hemostats, cautery devices, suction tools, etc. In the conventional operating theater, the surgeon's access to these instruments depends largely on the surgical assistant. The assistant typically stages the instruments on a Mayo stand and one or more back tables, and delivers them to the surgeon as requested. After a task involving a particular subject instrument is completed, the assistant retrieves the instrument until it is called for again. This basic methodology has long been established and still remains in wide use, even though it presents a number of drawbacks.
The fidelity of interactions between the surgeon and surgical assistant depends to a large extent on the skill and training of the assistant. The assistant must respond promptly and accurately to the surgeon's requests in order to avoid delays and disruptions that may affect the surgeon's concentration and efficient execution of ongoing procedures. Experienced assistants should generally be able to anticipate which instruments may be requested at particular stages in an operation. The experienced assistant also knows which instruments are used in conjunction with other instruments, and which instruments require special handling or preparation before they are delivered to the surgeon. By virtue of such experience, the well-trained assistant can efficiently stage and handle instruments, with minimal delays and distraction to the surgeon.
Unfortunately, the amount of experience and ability among surgical assistants varies considerably. Many assistants are unfamiliar with certain procedures and thus fail to present desired instruments in an organized and timely manner. As a result, surgical procedures may be disrupted by delays and miscommunications involving instrument transfer. All too commonly, the surgeon's focus is drawn away from the operating field to direct activities of the assistant. At other times, inexperienced assistants will hand a surgeon the wrong instrument, either because the surgeon's instructions were misunderstood or the assistant improperly second-guessed the surgeon's needs. Often, instruments that are used repeatedly for a given procedure are retrieved and put away, even though the surgeon needs them back expediently. Other assistants leave instruments on the Mayo stand or operating field in a disorganized clutter, slowing delivery to the surgeon and creating additional confusion in the operating theater.
In addition to the lack of consistent training among surgical assistants, each doctor and assistant develops a unique working style and communication habits that can further complicate instrument transfer in the operating theater. Individual surgeons may select different operating procedures and instruments to achieve similar tasks, such that an assistant who is unfamiliar with a particular surgeon's preferences may be confused and inefficient at instrument transfer. This factor is especially significant in larger medical communities where doctors may practice in numerous hospitals and with a large number of different assistants. In this context, the fidelity of instrument transfer during operating procedures varies substantially, not only in accordance with the assistant's training but also in accordance with the degree of familiarity between the surgeon and assistant.
Other factors which complicate instrument transfer during surgical procedures include the varying demands placed on the assistant. For example, many complex operations involve multiple surgeons, each relying on a single assistant for instrument delivery and retrieval. For coronary artery bypass grafting, aortoiliac or femoropopliteal bypass grafting, complex burn and plastic reconstructions, and abdominal perineal resections, two surgeons typically operate simultaneously on two separate areas of the patient's body and call for support from one assistant. The assistant must transit between both surgeons and attend to their instrument needs in a timely and accurate fashion. During other procedures, the surgical assistant may be assigned additional tasks besides instrument handling. For example, assistants are commonly called upon to hold retractors, suction tools and other instruments in place while the surgeon proceeds with an operation. At other times, the assistant is asked to use one or both hands to help in some way with an operation. In these instances, the assistant may be unable to reach the Mayo stand or back table while performing the secondary task.
Other difficulties involved in instrument transfer during surgery arise from the required positioning of the patient, doctor and assistant during particular operations. For example, in many operations involving the genitourinary tract, anus, and perineum, the assistant and Mayo stand are both positioned behind the surgeon with the patient in a lithotomy position and the surgeon standing or seated between the patient's legs. Common examples of operations staged in this manner include total vaginal hysterectomy, radical perineal prostatectomy, cystourethroscopy, hysteroscopy, and transanal procedures. Under these circumstances, instruments are not readily transferred to the surgeon by the surgical assistant, who must avoid handing tools over the surgeon's shoulder or below waist level to maintain sterility. Likewise, returning instruments within the sterile field between a seated surgeon and standing assistant is challenging and inefficient, especially when the same instrument will be needed again shortly after it is returned.
To circumvent the foregoing difficulties that attend surgical instrument handling in the operating theater, many surgeons maintain increased control over their instruments. This is particularly true in the case of instruments that are used frequently but not continuously during a procedure, where the surgeon does not want spend the time and effort necessary to return, and shortly thereafter retrieve, the same instrument. Often, such tools which are used repeatedly, for example, a Bovie cautery, suction tool, dissecting forceps, Metzenbaum scissors or hemostat, are not relinquished to the assistant but are held or placed close at hand by the surgeon. Holding on to an instrument in this manner can impede the surgeon's concentration and dexterity. Other problems arise if the surgeon elects to place an instrument close at hand, which often involves placement of the instrument on a sterile drape covering the patient's head, chest, abdomen, or lower extremity. Such tenuous placement of instruments may result in confusion and delays for both the surgeon and the assistant which can be exacerbated by the differing positions of patients in different procedures (e.g., supine, prone jackknife, lateral decubitus, lithotomy, rotated, or other). In all patient positions, unattended instruments can endanger the patient who lies unseen beneath the drapes, can fall out of the sterile field, or be forgotten by the surgeon who then requests tools from the assistant who cannot find or retrieve them.
Various devices and methods have been proposed to facilitate instrument handling in the operating theater. Among these methods and devices, some are intended to provide the surgeon with increased control over instrument access and relieve the surgical assistant of instrument handling demands. Thus, U.S. Pat. No. 4,665,566, issued to Garrow on May 19, 1987, discloses an instrument retaining device which is a strap-like clamp for securing instruments within the surgeon's reach during an operation. The device is primarily adapted for securing tubes and requires mounting of the straps around an available surface. Thus, use of the device is primarily limited to circumstances where an extremity of the patient or other object is conveniently available to secure the straps around. Moreover, the device is not particularly well adapted to secure other instruments that are more typically desired to be left in the surgeon's control.
Other designs which have been proposed for retaining surgical instruments within reach of the surgeon include various pouch-like receptacles that are affixed, or attachable to, a surface within the operating theater to secure instruments without the need of mounting straps. Exemplifying such designs is an instrument pouch marketed by the 3M company under the name "Steri-Drape." This pouch is designed to attach by adhesive strips to the exterior of a surgical drape placed over the patient. The pouch has pockets to receive instruments and is provided as a disposable unit. An alternative design offered by 3M is a surgical drape to which are affixed multiple instrument pouches for the surgeon to secure and access instruments during an operation.
Yet additional designs incorporate removably attachable pouches that are designed to mount on a patient's body or surgical drape covering the patient's body. For example, U.S. Pat. No. 5,081,111, issued to Corbit, Jr., et al. on Jan. 21, 1992, discloses a disposable instrument pouch with receptacles and closable flaps to secure instruments that can be attached adhesively to a patient's body or surgical drape. Similarly, U.S. Pat. No. 5,036,866, issued to Eldrige, Jr., et al. on Aug. 6, 1992, discloses an instrument pouch attachable to a surgical drape by specially-designed tab that interlocks with a slot on the surgical drape. The pouch has planar walls spaced apart by a ridge and is designed with perforations to allow sterilization and re-use.
Each of the foregoing devices suffer similar drawbacks in terms of their common designs for attachment to a patient or other surface. These surfaces are limited in the operating theater and frequently change between operations--based on such changing factors as patient positioning and varying placement and configuration of operating equipment, etc. In this context, the changing location and positioning of the instrument retainer can lead to difficulties in locating and handling instruments. Such tenuous placement of instruments in the surgical field does not provide adequate security to prevent against movement or dropping of instruments outside the sterile field (i.e., between the surgeon's clavicles and the surface of the operating table). Moreover, attachment of instruments, particularly heavy or sharp instruments, to a thin drape covering the patient is ill-advised in the context of patient comfort and safety. Likewise, fixation of an instrument pouch to a particular stationary object within the operating field limits the surgeon's mobility by dictating placement of the surgeon to access the stored instruments. Finally, the pouch designs and mounting configurations of these previously proposed instrument retaining devices are not conducive to storage and retrieval of larger and more cumbersome instruments associated with the rapidly growing discipline of laparoscopic surgery.
Thus, a clear need remains in the art for a surgical instrument storage device that will facilitate instrument control and retrieval by the surgeon, free the surgical assistant from excessive instrument handling tasks, and reduce clutter and confusion in the surgical theater.
A related need exists for a surgical instrument storage device that will allow the surgeon to securely store a number of surgical instruments having a wide range of sizes and shapes, and to quickly and accurately retrieve them.
An additional need remains in the art for a surgical instrument storage device that will allow for repetitive storage and retrieval of instruments during operations while the device is situated securely within the sterile field to avoid contamination.
Another need remains in the art for a surgical instrument storage device that is adaptable for use within a wide range of surgical settings and procedures.
Yet an additional need remains in the art for a surgical instrument storage device that is economical to manufacture and use, and which is disposable or sterilizable to accommodate safe surgical practices.